Soleno Therapeutics(SLNO) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company used $32.8 million in cash for operating activities during Q1 2025, ending the period with $290 million in cash, cash equivalents, and marketable securities, down from $318.6 million as of December 31, 2024 [18] - Research and development expenses for Q1 2025 were $13.5 million, compared to $14.6 million in the same period of 2024 [19] - Selling, general, and administrative expenses for Q1 2025 were $29.3 million, up from $8.5 million in Q1 2024 [19] - The net loss for Q1 2025 was approximately $43.8 million, or $0.95 per share, compared to a net loss of $21.4 million, or $0.59 per share, in Q1 2024 [20] Business Line Data and Key Metrics Changes - The company had not yet commercialized VICAT XR in Q1 2025, resulting in no revenue for the period [19] - As of the end of the reporting period, the company received 268 start forms for VICAT XR in 29 business days since FDA approval [14] Market Data and Key Metrics Changes - The addressable market for VICAT XR in the U.S. is estimated at approximately 10,000 individuals diagnosed with Prader Willi syndrome (PWS) [11] - The company estimates that there are about 9,500 patients with PWS in the EU and the UK, with plans to submit a Marketing Authorization Application (MAA) to the EMA in the first half of the year [22] Company Strategy and Development Direction - The company aims to establish VICAT XR as the standard of care for hyperphagia in PWS and is focused on operational excellence and communicating the drug's value proposition [12] - The company is committed to ensuring that VICAT XR is accessible to all eligible patients and has set up a patient services contact point to assist with payer access [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early response from the PWS community to the availability of VICAT XR in the U.S. but cautioned that revenue generation would take time due to the typical lag in commercial launches [24] - The company anticipates modest revenues for Q2 2025 as they navigate the process of converting start forms into actual sales [28] Other Important Information - The company has secured an additional $75 million under a loan agreement to support operations over the next 18 months following the approval of VICAT XR [18] - The company is actively participating in payer outreach to emphasize the complexity of hyperphagia in PWS patients and the need for new therapeutic options [16] Q&A Session Summary Question: How soon can start forms be converted into revenue? - Management indicated that several steps are involved in converting start forms into revenue, and they expect modest revenues for Q2 [28] Question: What percentage of Phase III program patients are reflected in current start forms? - The majority of the 77 patients from the Phase III program have submitted start forms, with 60 of those in the U.S. [33] Question: How does coverage differ on a state-by-state level? - The company is participating in the Medicaid program, with states varying in their timelines for policy decisions [40] Question: What is the competitive landscape for hyperphagia treatments? - The main competitor is ACADIA with Carbitocin, which has faced regulatory challenges, while another competitor is starting a Phase III study [77] Question: How does the company view the European market opportunity? - The company sees significant potential in Europe, with a similar number of PWS patients as in the U.S. and a strong unmet need for treatment [80]